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Ruzurgi
Published
Product name
Ruzurgi
Active ingredient
Amifampridine
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ruzurgi (amifampridine) was approved for the following therapeutic use:
Ruzurgi is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above.
How this medicine works
The mechanism by which amifampridine exerts its therapeutic effect in Lambert-Eaton myasthenic syndrome (LEMS) patients has not been fully elucidated. Amifampridine is a broad-spectrum potassium channel blocker.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Ruzurgi was considered favourable for the therapeutic use approved.
Sponsor
ARTG details